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Panels › Orthopedic › Product code OSH · Class 2

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Regulation 888.3070

0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in OSH

Company510(k)sRecalls
K2m, Inc.60
OrthoPediatrics Corp.31
Medicrea International30
Medtronic Sofamor Danek20
Astura Medical10
Biomet Spine (Aka Ebi, LLC)10
Depuy Spine, A Johnson & Johnson Company10
Globus Medical, Inc.10
Implanet, S.A.10
Decided510(k)Device and applicantCode
Apr 8, 2016K153446OLYMPIC Posterior Spinal Fixation System
Astura Medical
OSH
Mar 13, 2014K140276CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek
OSH
Nov 8, 2013K132574PASS LP SPINAL SYSTEM
Medicrea International, FR
OSH
Oct 10, 2013K132303IMPLANET SPINE SYSTEM
Implanet, S.A.
OSH
Oct 3, 2013K132575PASS LP SPINAL SYSTEM
Medicrea International, FR
OSH
Sep 12, 2013K131802EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM
Depuy Spine, A Johnson & Johnson Company
OSH
Sep 4, 2013K131615POLARIS SPINAL SYSTEM
Biomet Spine (Aka Ebi, LLC)
OSH
Aug 30, 2013K131784RANGE SPINAL SYSTEM
K2m, Inc.
OSH
Jun 5, 2013K131321CD HORIZON SPINAL SYSTEM
Medtronic Sofamor Danek USA
OSH
May 13, 2013K124058CREO STABILIZATION SYSTEM
Globus Medical, Inc.
OSH
May 9, 2013K131030RANGE SPINAL SYSTEM
K2m, Inc.
OSH
May 8, 2013K130655RESPONSE SPINE SYSTEM
OrthoPediatrics Corp.
OSH
May 8, 2013K122877RANGE SPINAL SYSTEM, SMALL STATURE
K2m, Inc.
OSH
May 2, 2013K130330RANGE SPINAL SYSTEM
K2m, Inc.
OSH
Feb 13, 2013K123412RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K2m, Inc.
OSH
Feb 5, 2013K123138PASS LP SPINAL SYSTEM
Medicrea International, FR
OSH
Sep 11, 2012K121630RANGE SPINAL SYSTEM
K2m, Inc.
OSH
Jun 19, 2012K121250OP SPINE SYSTEM
OrthoPediatrics Corp.
OSH
Apr 16, 2012K120291OP SPINE SYSTEM
OrthoPediatrics Corp.
OSH

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